Coronary Sinus Anchored Catheter for His Bundle Pacing
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Solution Overview
Problem
Current methods for delivering His bundle pacing leads face challenges in accurately identifying and deploying the lead to the correct site due to anatomical specificity and differences in approach angles between mapping catheters and pacing leads.
Innovation Solution
A catheter system with an atraumatic anchoring structure that pivots at the coronary sinus ostium or coronary sinus, allowing the pacing lead to map and identify the His bundle site while being anchored, and then deploy the lead with adjustable shape and rotation for precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a mapping catheter is used to identify the His bundle and then a pacing lead is independently navigated to that site, then the His bundle can be identified, but the difficulty of accurately delivering the pacing lead to the identified site increases due to different approach angles
Solution Approach 1:
The patent combines the mapping catheter and pacing lead delivery system into a single integrated device. The pacing lead is delivered through the same catheter that performs mapping, eliminating the need for separate navigation steps and ensuring consistent approach angle from the coronary sinus ostium to the His bundle target site.
Solution Approach 2:
The catheter serves as an intermediary structure that provides a stable platform for both mapping and lead delivery. The distal end of the catheter is anchored at the coronary sinus ostium, creating a reliable pivot point that facilitates precise positioning of the pacing lead at the target site while maintaining consistent geometric relationship.
2Stability of the object's composition
If the catheter is anchored at the coronary sinus ostium to provide stability for lead delivery, then control and stability are improved, but the complexity of the device increases due to the anchoring mechanism
Solution Approach 1:
The catheter is divided into distinct functional segments: a distal anchoring portion with the anchoring structure, a mid-section with the lead delivery lumen, and a proximal control portion. This segmentation allows the anchoring mechanism to be optimized independently while simplifying the overall device design and operation.
Solution Approach 2:
The anchoring structure is deployed first to establish a stable base at the coronary sinus ostium before the pacing lead is delivered. This preliminary action ensures that the catheter remains stationary during the subsequent lead delivery and positioning steps, improving overall procedure reliability.
3Ease of operation
If the lead receiving lumen has a ramped or curved portion to cause lateral projection of the lead, then the lead can be deployed at the correct angle, but the manufacturing precision requirements increase
Solution Approach 1:
The lead receiving lumen incorporates a ramped or curved portion with specific geometric parameters (angle, radius of curvature, length) that are optimized to automatically position the lead at the correct deployment angle. By carefully selecting these parameters, the device achieves reliable angular positioning without requiring ultra-precise manufacturing tolerances.
Solution Approach 2:
The use of a curved or ramped portion in the lead receiving lumen provides a smooth transition that guides the lead into the desired lateral projection. The curved geometry naturally directs the lead at the correct angle as it exits the catheter, simplifying both manufacturing and operation compared to sharp angular features.
Data Source
AI summary
Disclosed herein is a catheter for delivering an implantable medical lead to an implantation site near an ostium leading to a proximal region of a coronary sinus. The catheter includes a distal end, a proximal end opposite the distal end, a tubular body extending between the distal and proximal ends, an atraumatic fixation structure defining a distal termination of the distal end, and a lead receiving lumen. The atraumatic fixation structure is configured to enter the ostium and passively pivotally anchor with the proximal region of the coronary sinus. The lead receiving lumen extends along the tubular body from the proximal end to an opening defined in a side of the tubular body near the distal end and proximal the atraumatic fixation structure.